Minor use pesticides are crop protection products targeting value specialty crops with small acreage, as well as controlling minor pests on major crops. Due to the low financial incentive for agrochemical companies to register their products alone, the lack of available pesticides led to illegal uses and crop loss in China until the regulatory reform. In 2017, China MoARA issued the ministry regulation, “Administrative Measures for the Registration of Pesticides”, constituting a characteristic mechanism consists of cost-sharing among multiple applicants, and an extrapolation scheme to use residue and efficacy data from crop groups, as well as the fast-track process introduced last year. In this article, we will introduce the scope, extrapolation, field trial and application procedures for minor-use pesticide registration.
Dynamic Scope and Crop Grouping
MoARA adopts constant readjustment to the pesticide, crop, and pests for minor uses and 3 lists were issued to help applicants to determine the scope:
- List of Minor Crops with Low Availability of Crop Protection Solution;
- List of Crop Groups for Extrapolated Use of Residue Data;
- List of Crop Groups for Extrapolated Use of Efficacy Data;
The “List of Crop Grouping for Extrapolated Use of Residue Data” consists of crop group/sub-group, specific crops, and representative crops of the group. If the applicant completed the residue test of the representative crop and 1 or 2 specific crops with the same GAP (Good Agriculture Practice) condition, the data can be extrapolated to support the whole group. The number and test sites and selection of their locations shall conform to Annex 6 and Annex 9 of the “MoARA Announcement 2569- Data Requirements on Pesticide Registration” and the extrapolated use of residue data is inapplicable to post-harvest solutions.
The “List of Crop Grouping for Extrapolated Use of Efficacy Data” specifies the representative crop/pest and extrapolatable minor crop/pests. To extrapolate the data to the whole group, the applicant may complete the trial on the representative crop and pests, or a representative pest on 3 extrapolatable minor crops, following the requirements on the number and location of trial sites previously mentioned. If the pesticide was tested with different content or formulation type, a crop safety test at a laboratory scale would additionally be required. MoARA recognized that even the same pest/disease on different crops could be caused by different insects/pathogens, therefore, a bioactivity test would be conditionally required. Furthermore, manufacturers need to add off-label precaution, instructing users to perform a small-scale crop safety validation trial with different concentrations before the extrapolated usage.
Expedite Review and Data Waive
On September 30, 2020, China MoARA opened a fast-track process for 4 categories of pesticides:
- Microbial pesticides, botanical pesticides, and biochemical pesticides, as well as fermentation-derived agricultural antibiotics;
- Minor-use pesticides underwent the joint trial organized by agricultural authorities from the provincial level or above;
- New pesticides substituting existing highly toxic pesticides;
- Other pesticides identified by MoARA
In addition to the cost spread through the joint trial sponsored by different applicants, parts of the trial data can directly be exempted in some cases, notably the “Technical Specification for the Residue Risk Control of Minor-use Pesticides” issued in May 2020. The document specifies 505 indicators of formulation type, application method, application rate, number of applications, preharvest interval for 67 active ingredients used on 84 minor crops. A registered pesticide may apply for label expansion without conducting a residue trial in the following situation：
- The active ingredient was included in the specification and the single-element pesticide has the same formulation type;
- The pesticide has the same application method, less or equal maximum application rate, number of applications and longer or equal preharvest interval.
Joint Trial Management
Generally, only insecticides, acaricides and fungicides with the same active ingredient, and content level and registered against the same pest on different crops can be jointly trialed. If the pesticides were processed in different formulation types or concentrations, a representative product could be selected for residue and efficacy trial, and other products need to conduct an additional trial to validate the efficacy.
The joint trial should be filed at the provincial agricultural department and carried out by MoARA designated testing facilities on a “one trial site, one testing facility within the same province” basis. The trial site and the testing facility should situate in the planting regions or pest-infested regions. If there is no available qualified testing facility, the applicants may apply to MoARA for the appointment. The designated or appointed testing facilities will jointly formulate the trial plan with provincial authorities and list all the participating manufacturers for further sampling.
After the trial was complete, the testing facilities will submit the GLP-format report to provincial departments for preliminary review and a technical opinion will be concluded through a centralized review organized by MoARA.
Each participant manufacturer needs to apply for label expansion by submitting an application form, copies of registration certificate, label and product manual, a summary on other products participate the joint trial and evidentiary materials supporting the participation of the joint trial or acquisition of data generated by government, as well as toxicological or environmental data conditionally required depending on the product, crop, target pest, application method and use scenario.
For each minor use proposed, at least a full set of test data including product chemistry, toxicity, environmental impacts, residue, and efficacy should be required. It is recommended to submit the test data on the product used in the joint trial.